Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio’s commercial platform.
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INSIGHTS ON THE LATEST NEVA TECHNOLOGY
IN CORONARY ARTERIAL OCCLUSION
FIRST PASS SUCCESS WITH ALL CLOT TYPES IN STROKE THROMBECTOMY
Changing Outcomes CHANGING LIVES!
Designed for first pass success with all clot types in stroke thrombectomy
Currently not available in your region.
Innovation in progress
in development…
When complexity requires simplicity
in peripheral arterial occlusion
A specific design
A decisive solution
for post aSAH cerebal vasospasm
The next frontier in thrombectomy
designed to maximize clot retention
Currently not available in your region.
Choose to remove
large clot burden in coronary arterial occlusion
Currently not available in your region.
Innovation in progress
in development…
Designed for first pass success with all clot types in stroke thrombectomy
Currently not available in your region.
A specific design
A decisive solution
for post aSAH cerebal vasospasm
The next frontier in thrombectomy
designed to maximize clot retention
Currently not available in your region.
Innovation in progress
in development…
Designed for first pass success with all clot types in stroke thrombectomy
Innovation in progress
in development…
When complexity
requires simplicity
in peripheral arterial occlusion
Currently not available in your region.
A specific design
A decisive solution
for post aSAH cerebral vasospasm
This product is currently not available in your region
The next frontier in thrombectomy
designed to maximize clot retention
Choose to remove
large clot burden in coronary
arterial occlusion
Innovation in progress
in development…
Designed for first pass success with all clot types in stroke thrombectomy
A specific design
A decisive solution
for post aSAH cerebral vasospasm
This product is currently not available in your region
The next frontier in thrombectomy
designed to maximize clot retention
CLOT BURDEN: A MAJOR CARDIOVASCULAR HEALTH CONCERN
A large portion of acute arterial blockages are comprised of clots and cause nearly a third of all fatalities and disabilities worldwide
Neurovascular
Occlusion of a brain artery
15m
Strokes each year
#1
Cause of severe disability
#2
Cause of death worldwide
~80%
Due to clots
Cardiovascular
Occlusion of a heart artery
8.5m
Heart attacks each year
#1
Cause of death worldwide (CVD)
~30%
Due to clots
Peripheral Vascular
Occlusion of an artery anywhere in the body
2.5m
Acute limb ischemia each year
20-25%
Will die at year one
20-25%
Will need major amputation at year one
~80%
Due to clots
References upon request
PHYSICIANS SAY
“Our experience with NeVa has been fantastic, with high complete recanalization rates as of the first attempt and we’re excited to be among the first centers to use the NeVa NET.”
Dr Paul Bhogal
NHS Royal London, London, UK
“enVast could provide a new therapeutic opportunity for myocardial infarct patients with large thrombus burden, who still represent a major challenge for procedural success and long-term outcomes.”
Prof Dr Marco Valgimigli
Istituto Cardiocentro Ticino, Lugano, Switzerland
PHYSICIANS SAY
“Patients with acute limb ischemia often present a complex medical history and pose significant challenges for physicians who must navigate severely diseased arteries and work within narrow, stenotic vessels. In such cases, when access is difficult, or when working below the knee, the low profile and excellent deliverability of pVasc make it an especially valuable tool.”
Dr Frank Arko
Sanger Heart and Vascular Institute, Charlotte, North Carolina.
“Complete angiographic resolution of vasospasm with one pass! It’s my new go-to device for symptomatic vasospasm.”
Dr Shahid Nimjee
The Ohio State University Wexner Medical Center, Columbus, Ohio
Innovation In Action
COMPLETE FIRST PASS RECANALIZATION WITH NEVA NET IN A MIDDLE CEREBRAL ARTERY OCCLUSION
Dr Fernando Ezequiel Petra, Mendoza, Argentina
LARGE THROMBUS BURDEN MANAGEMENT IN AN ECTATIC LEFT ANTERIOR DESCENDING CORONARY ARTERY
Dr Dario Bongiovanni, Augsburg, Germany; Dr Francesco Loizzi, Bari, Italy; Dr Antonio Landi and Prof Marco Valgimigli, Lugano, Switzerland
VESALIO NEWS
Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology
The FDA clearances expand Vesalio’s thrombectomy portfolio to support its growth strategy in the rapidly expanding multi-billion-dollar global thrombectomy market.
Vesalio Announces Launch of pVasc Study in the U.S. While Featuring the pVasc Thrombectomy System at VIVA, VEITH, and TCT
Vesalio Introduces pVasc™ U.S. Clinical Study to capture real-world data and optimize results for patients suffering from peripheral vascular disease.
Vesalio launches pVasc Thrombectomy System in the U.S. for peripheral occlusions
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
VESALIO Introduces NeVa NET 4.0 mm Following International Success of NeVa NET 5.5 mm
Vesalio hires Bob Bushok as VP of U.S. Sales and announces high first-pass rates and favorable safety profile in a…
Vesalio appoints CFO and announces company headquarters in Dallas, Texas
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology
The FDA clearance of enVast redefines coronary thrombectomy treatment and further expands Vesalio’s commercial platform.
Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology
The FDA clearances expand Vesalio’s thrombectomy portfolio to support its growth strategy in the rapidly expanding multi-billion-dollar global thrombectomy market.
Vesalio Announces Launch of pVasc Study in the U.S. While Featuring the pVasc Thrombectomy System at VIVA, VEITH, and TCT
Vesalio Introduces pVasc™ U.S. Clinical Study to capture real-world data and optimize results for patients suffering from peripheral vascular disease.
Vesalio launches pVasc Thrombectomy System in the U.S. for peripheral occlusions
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
VESALIO Introduces NeVa NET 4.0 mm Following International Success of NeVa NET 5.5 mm
Vesalio hires Bob Bushok as VP of U.S. Sales and announces high first-pass rates and favorable safety profile in a…
Vesalio appoints CFO and announces company headquarters in Dallas, Texas
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
